Naturalistic Study of Microdosing With Psilocybin

NCT05160220 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to understand the neural, cognitive and behavioral effects of low doses of psilocybin administered in the form of dried mushroom material (0.5 g of Psilocybe cubensis) consumed in natural settings following a placebo-controlled double-blind experimental design.

Conditions

Cognitive Change; Creativity; Mood Change; Sleep

Keywords

psilocybin; psychedelics; nootropics; microdosing; EEG; cognition; creativity; behavior; sleep

Outcome Measures

Primary Outcomes (11)

• Resting state oscillations measured with EEG

  Our goal is to study changes in spectral content before and during the acute effects with the purpose of comparing changes with those observed under higher doses of psilocybin.

  1 week

• Attention

  Measured performance in the attentional blink paradigm

  1 week

• Inhibitory control

  Measured using the go/no go experimental paradigm

  1 week

• Conscious access

  Measured using the backward masking paradigm

  1 week

• Visual perception

  Measured using the binocular rivalry paradigm

  1 week

• Physical activity

  Measured using wrist actigraphy using a smartwach

  1 week

• Divergent thinking

  Measured using the Alternative Uses Task (AUT)

  1 week

• Attention

  Measured using the hiearchical mismatch negativity paradigm combined with EEG

  1 week

• Cognitive flexibility

  Measured using the stroop task

  1 week

• Convergent thinking

  Measured using the Remote Associations Task (RAT)

  1 week

• Convergent thinking

  Measured using the Wallach-Kogan test (WK)

  1 week

Secondary Outcomes (4)

• Effect positive/negative affect and well-being

  1 week

• Effects on anxiety

  1 week

• Effects on personality

  1 week

• Concentration of psilocybin in the dried material

  1 week

Study Arms (2)

Psilocybe cubensis

ACTIVE COMPARATOR

0.5 g dried and powdered P. cubensis in gel capsules, dosing on two separate days, separated by one week from the placebo, randomized order.

Drug: Psilocybin

Inactive placebo

PLACEBO COMPARATOR

Same weight of inactive placebo in gel capsules, dosing on two separate days, separated by one week from the placebo, randomized order.

Drug: Placebo

Interventions

Psilocybin DRUG

0.5 g dried Psilocybe cubensis mushroom material, 0.8 mg psilocybin.

Psilocybe cubensis

Placebo DRUG

0.5 g dried edible non-psychoactive mushroom material.

Inactive placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and woman with more than 21 years.
• Participans are planning to microdose using their own dried mushroom material and adhere to the experimental protocol.
• No active psychiatric conditions requiring treatment with psychotropic medications.
• Able to provide informed consent.
• Excusion Criteria:
• Use of psychotropic medication during the study, including stimulants such as caffeine.
• Prior adverse reactions to psychedelics according to the Challenging Experiences Questionnaire administered during initial screening.
• Pregnant women or women during lactation
• History of high or low blood pressure or other cardiovascular risks.

Sponsors & Collaborators

• National Council of Scientific and Technical Research, Argentina: lead

Study Sites (1)

Instituto de Fisica de Buenos Aires (IFIBA)

Buenos Aires, 1428, Argentina

Location

MeSH Terms

Conditions

Behavior

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Enzo Tagliazucchi, PhD

  National Council of Scientific and Technical Research, Argentina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: December 16, 2021
• Study Start: January 20, 2021
• Primary Completion: June 30, 2021
• Study Completion: October 1, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication, indefinite.
• Access Criteria: Public

Locations

AR (1)